Download OV LiPlaCis™ - First DRP-positive Breast Cancer Patient obtained

Oncology Venture Sweden AB
Hoersholm, Denmark, August 23rd 2016
Press release
OV LiPlaCis™ - First DRP-positive Breast Cancer Patient obtained
reduction of tumor
Hoersholm, Denmark; August 23rd, 2016 – Oncology Venture Sweden AB (OV:ST) announces that the first
patient with metastatic breast cancer included in the extension – proof of concept part of the LiPlaCis trial
has obtained a confirmed Partial Remission (ie >30% reduction of her tumor). The patient has – in addition to
surgery and adjuvant treatment received five prior medical treatments of her disease with the best response
of Stable Disease (i.e. no change in the overall measurement of the tumor burden) and is a patient with a
hard to treat tumor.
The patient is the first out of 12-15 patients whose tumor tissue has been screened for genomic expression
by the Drug Response Predictor – DRP™ and found to be in the top 10% of patients who have the highest
likelihood of response to LiPlaCis treatment.
The DRP is designed to enable a high response rate and give Breast Cancer patients a new effective
personalized treatment opportunity.
The extension PoC phase will take approximately 12 months, with interim data expected during this period.
More than 1100 patients have had their tumors DRP-screened beforehand. The included patients in the LiPlaCis
proof of concept study will be in the top 10% of high likely responders according to the DRP, by which patients’
individual biopsies are analyzed for sensitivity (effect) to LiPlaCis. Using a conservative cut off of top 10% is to
demonstrate the ability of the DRP to select sensitive patients. Later, the cut off is expected to be less
conservative, as the relevant patient population is expected to be at a cut off around 30-40%.
"Knowing that this in one patient out of up to 15 and therefore not data that can promise that LiPlaCis will be
approved, I am however happy every time OVs drug and Professor Knudsen’s Drug Response Predictor
technology makes a difference for a patient. LiPlaCis - OV’s lead product - is the first prospective study which is
set up to demonstrate that our DRP can select those patients who will benefit from the treatment ”, said
Adjunct Professor Peter Buhl Jensen, MD, PhD and CEO of Oncology Venture. ”The hope is that we can we can
keep delivering good results in the study and develop a new, effective personalized treatment option for Breast
Cancer patients with metastatic disease. We believe the future lies in personalized treatment, and that
Oncology Venture is at the forefront with its DRP technology”, Dr. Buhl Jensen further commented.
About LiPlaCis
Cisplatin is one of the most widely used drugs in the treatment of cancer due to its documented efficacy in a
number of tumour types. Cisplatin is used in the treatment of large indications such as Lung Cancer (EU+US ≈
480,000 new cases annually), Head and Neck Cancer (500,000 cases annually worldwide) Bladder Cancer
(EU+US ≈ 170,000 annually) and Ovarian Cancer (EU+US ≈ 71,000 annually). The lipid formulation LiPlaCis is the
answer to a well-established need for improving cisplatin therapy and the formulation of the drug, so that a
more selective up-take of cisplatin takes place at the site of the tumor.
More About LiPlaCis™ and the Clinical Testing
The Phase 1 study to evaluate the safety and tolerability of LiPlaCis in patients with advanced tumours has
been conducted at two Oncology sites at University Hospitals in Copenhagen and has included 20 patients in
the dose escalation part of a phase 1 study in solid tumors. The LiPlaCis program has now moved into the
extension proof of concept phase, which is part of the phase 1 application where patients with a specific
disease – here metastatic Breast Cancer - are included to investigate early Proof of Concept, i.e. effect of the
drug. 75mg LiPlaCis™/patient is administered intravenously in weekly cycles on day 1 and day 8. Upon the
investigator’s judgement, the patient may continue treatment for more than three cycles when benefiting from
the study drug.
Oncology Venture Sweden AB
Hoersholm, Denmark, August 23rd 2016
Press release
About the Drug Response Predictor - DRP™ - Screening Tool
Oncology Venture uses the MPI DRP™ to select those patients that by the gene signature in their cancer is
found to have a high likelihood of response to the drug. The goal is to develop the drug for the right patients
and by screening patients before treatment the response rate can be significantly increased.
This DRP™ method builds on the comparison of sensitive vs. resistant human cancer cell lines including
genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems
biology network. The DRP™ based on microRNA is used on certain products where the DRP™ based on
messenger RNA is more broadly useable and more validated.
For further information, please contact
CEO Peter Buhl Jensen, Adjunct professor, MD, PhD
Telephone: +45 21 60 89 22
E-mail: [email protected]
Ulla Hald Buhl, COO, IR & Communication
Telephone +45 21 70 10 49
E-mail: [email protected]
This information is information that Oncology Venture Sweden AB is obliged to make public pursuant to the EU
Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person
set out above, on 23rd august 2016.
About Oncology Venture Sweden AB
Oncology Venture Sweden AB is engaged in the research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS.
Oncology Venture has a license to use Drug Response Prediction – DRP™ – in order to significantly increase the probability of success in clinical trials. DRP™ has
proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment in cancer patients in 29 of the 37 clinical studies that
were examined. The Company uses a model that alters the odds in comparison with traditional pharmaceutical development. Instead of treating all patients
with a particular type of cancer, patients are screened first and only those who are most likely to respond to the treatment will be treated. Via a more welldefined patient group, the risk and costs are reduced while the development process becomes more efficient.
The current product portfolio: LiPlaCis™, for Breast Cancer, Irofulven, developed from a fungus, for Prostate Cancer, and APO010, an immuno-oncology product
for Multiple Myeloma.